Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001459819
Ethics application status
Approved
Date submitted
16/09/2021
Date registered
26/10/2021
Date last updated
28/09/2022
Date data sharing statement initially provided
26/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Self Management and Remote Monitoring of Heart Failure and Chronic Obstructive Airways Disease using a Smart Phone Application
Scientific title
Self Management and Remote Monitoring of Heart Failure and Chronic Obstructive Airways Disease using a Smart Phone Application in patients referred of admitted to hospital with these conditions. Assessing impact on quality of life, symptoms, and hospitalisations.
Secondary ID [1] 305334 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic obstructive pulmonary disease 323652 0
heart failure 323653 0
Condition category
Condition code
Respiratory 321191 321191 0 0
Chronic obstructive pulmonary disease
Cardiovascular 321192 321192 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients randomised to the intervention group enter their symptoms daily for 30 days on the smart phone application. The application used is called Mentegram.
The symptoms that are questioned are different for heart failure and COPD. The estimated time each day to enter the symptoms is 2 minutes. A deterioration in symptom control results in an immediate automatic prompt to contact their General Practitioner. Patients who do not report having contacted their GP within 24 hours then contacted via the research team using telephone to determine whether the patient has seen/is planning to see their GP, if they have not made contact with their GP and why. The hospital research team will look at the patient details and form an individualised response which includes, but is not limited to, alerting the patient’s nominated GP and their hospital treating team
Additionally patients who do not enter their daily report are contacted via telephone to perform a welfare check.
Weekly links to self-management education tutorials will be sent to the participants through the application. This education material consists of links to publicly available education material from the Lung Foundation Australia (lungfoundation.com.au), the Heart Foundation (www.heartfoundation.org.au) and WA Department of Health (www.healthywa.wa.gov.au). The estimated time to read the educational material is 10 minutes, and use of the link is tracked via the Smart phone application.
The subjects can enter the data at any location and adherence is tracked through the smart phone application.
Intervention code [1] 321743 0
Prevention
Comparator / control treatment
The control group also use the smart phone application over a 30 day period, but only to receive the weekly education materials. They do not enter their symptoms daily and do not have any additional symptom review or welfare checks.
Control group
Active

Outcomes
Primary outcome [1] 328985 0
Change in quality of life measures as measured by SF-36
Timepoint [1] 328985 0
30 days post-randomisation
Secondary outcome [1] 401025 0
change in self reported disease specific symptoms as measured using the Smart phone application. The COPD Assessment Tool will be used for COPD patients and Kansas City Cardiomyopathy Questionnaire for heart failure patients,
Timepoint [1] 401025 0
30 days post randomisation
Secondary outcome [2] 401026 0
Hospitalisation, as measured by length of stay. Data will be collected via the electronic component of patient medical records.
Timepoint [2] 401026 0
1, 3 and 6 months post-randomisation
Secondary outcome [3] 401027 0
patient satisfaction as measured by study specific questionnaire via the Smart phone
Timepoint [3] 401027 0
30 days post-randomisation
Secondary outcome [4] 401685 0
Frequency of hospital admission as determined via hospital medical records.
Timepoint [4] 401685 0
1, 3 and 6 months post-randomisation

Eligibility
Key inclusion criteria
Patients referred or admitted to hospital with a diagnosis of COPD or chronic heart failure.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. No regular access to a smart phone or email
2. Cognitive impairment precluding use of technology or unable to provide informed consent
3. Previously participated in this trial or the pilot trial
4. Children (<18years old)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation via computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be conducted using ‘Sealed Envelope’ program using block randomisation in groups of 10.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Proportions in each group will be reported with 95% confidence intervals. Differences in the change over time in SF36 domains between intervention and control patients will be investigated using random effects regression with maximum likelihood estimation that will prevent loss of cases if one of the two data points is missing. Length of stay and frequency of admission will be summarised using medians and first to third quartiles.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/11/2021
Actual
1/11/2021
Date of last participant enrolment
Anticipated
20/04/2022
Actual
20/04/2022
Date of last data collection
Anticipated
20/10/2022
Actual
Sample size
Target
200
Accrual to date
Final
55
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 20531 0
Armadale Kelmscott Memorial Hospital - Armadale
Recruitment hospital [2] 20532 0
Royal Perth Hospital - Perth
Recruitment hospital [3] 20533 0
St John of God Midland Public Hospital - Midland
Recruitment postcode(s) [1] 35313 0
6000 - Perth
Recruitment postcode(s) [2] 35314 0
6112 - Armadale
Recruitment postcode(s) [3] 35315 0
6056 - Midland

Funding & Sponsors
Funding source category [1] 305189 0
Hospital
Name [1] 305189 0
East Metropolitan Health Service
Country [1] 305189 0
Australia
Primary sponsor type
Hospital
Name
Armadale Health Service
Address
3056 Albany Highway Mt Nasura, Western Australia 6112
Country
Australia
Secondary sponsor category [1] 310721 0
None
Name [1] 310721 0
none
Address [1] 310721 0
Country [1] 310721 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305544 0
Royal Perth Hospital HREC
Ethics committee address [1] 305544 0
Ethics committee country [1] 305544 0
Australia
Date submitted for ethics approval [1] 305544 0
08/05/2020
Approval date [1] 305544 0
11/08/2020
Ethics approval number [1] 305544 0
RGS0000003933

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100734 0
Dr Joel Tate
Address 100734 0
Armadale Health Service
3056 Albany Highway, Mt Nasura, Western Australia, 6112
Country 100734 0
Australia
Phone 100734 0
+61 893912650
Fax 100734 0
Email 100734 0
[email protected]
Contact person for public queries
Name 100735 0
Joel Tate
Address 100735 0
Armadale Health Service
3056 Albany Highway, Mt Nasura, Western Australia, 6112
Country 100735 0
Australia
Phone 100735 0
+61 893912000
Fax 100735 0
Email 100735 0
[email protected]
Contact person for scientific queries
Name 100736 0
Joel Tate
Address 100736 0
Armadale Health Service
3056 Albany Highway, Mt Nasura, Western Australia 6112
Country 100736 0
Australia
Phone 100736 0
+61 893912000
Fax 100736 0
Email 100736 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.